FDAClass IIMay 16, 2018

Retractor f/Sciatic Nerve Long recall

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Why was Retractor f/Sciatic Nerve Long recalled?

There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: T104993, T108115, T114598, T140566, T140665, T140670, T140671, T140673, T141540, T143687, T144854, T145585, T145590, T145932, T146657, T147929, T148552, T148553, T149727, T149728 T151369, T151488, T152808, T152809, T153884, T155649, T958061

Product
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Recalling firm
Synthes (USA) Products LLC
Quantity
196
Distribution
US Nationwide and Canada
Recall date
May 16, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls